Accelerated review of children's drugs!

The State Council recently issued the "China Children's Development Program (2021-2030)" to encourage the development and production of children's drugs, speed up the application and approval of children's drugs, and propose to explore the formulation of a national children's essential drug list and timely update the children's prohibited drugs list

High standards, strict requirements, strong service

Top-level policy dividend release

For a long time, the research and development, production, and use of children’s drugs are different from adult drugs.

Encouragement and promotion of policies have greatly improved the efficiency of review and approval, thereby further accelerating the process of approval, registration and R&D and marketing of children's drugs

Kong Fanpu, director of the Center for Drug Evaluation of the National Medical Products Administration, said in an interview that children have higher requirements for drug safety, and that children’s drug use requires close cooperation in professional review, business management, technical support, inspection and verification; children’s drug review and review The approval of the green channel adheres to child-centered and clinical needs-oriented, high standards, strict requirements, and strong services to ensure that the quality of drugs after the market is guaranteed

The National Food and Drug Administration has continued to improve the priority review and approval policy for children's medications, opened a green channel for the review and approval of children's medications, and established a task management system for special coordination and supervision of designated personnel to improve the efficiency of review and approval; the official website of the Center for Drug Evaluation also opened a column for children's medications , To centrally disclose the relevant policies, regulations, guidelines and other documents of children’s medication to facilitate research institutions and enterprises to prepare application materials in advance and improve the efficiency of adoption

Priority review is good for innovation

Children's medication focuses on urgent clinical needs

It is worth noting that the new version of the "Administrative Measures for Drug Registration" was officially implemented in July 2020, and standardized arrangements have been made for priority review and approval; in addition, the "Working Procedures for Review of Drugs for Breakthrough Therapy (Trial)" and "Application for Conditional Approval of Drugs for Marketing" Guidance documents such as Work Procedures for Review and Approval (for Trial Implementation), and Work Procedures for Priority Review and Approval for Drug Marketing Authorization (for Trial Implementation) were announced, and the work for priority review and approval for drug marketing authorization has entered a new era

A series of policy guidance may usher in the climax of children's drug research and development

Children's medicines that have been included in the priority review and approval this year (click on the picture to enlarge)

It is not difficult to see that drugs such as attention deficit hyperactivity disorder, atopic dermatitis, epilepsy, neuroblastoma, precursor B-cell acute lymphoblastic leukemia, etc.

Nowadays, the drug regulatory authority conducts retrospective studies or explores real-world data to support the development of children’s drug development models for drugs that have not yet been approved for children’s use in the world, but domestic and foreign guidelines have clearly recommended drugs for use in children.

It is also understood that the "Technical Guidelines for Clinical Trials of Modified New Drugs for Children's Chemicals", "Technical Guidelines for the Writing of Children's Drug Related Information in the Instructions for Chemicals and Biological Products for Treatment", and "Technical Guidelines for Clinical Trials of Attention Deficit Hyperactivity Disorder Drugs" Several technical guidelines such as "Technical Guidelines for Clinical Research of Rare Disease Drugs" have been incorporated into the annual plan

Payment reform, catalog adjustment

Accelerate the conversion of market value

On October 25, 2018, the National Health Commission issued the "Notice on Printing and Distributing the National Essential Medicines List (2018 Edition)".
685 varieties were shortlisted.
The new edition of the Essential Medicines List came into effect on November 1, 2018
.
The catalogue focused on revising the categories, varieties, dosage forms, and specifications of children's drugs, and 22 new drugs for children in urgent clinical need were added
.

According to the requirements of the "Opinions on Improving the National Essential Medicine System" previously issued by the General Office of the State Council: Dynamically adjust and optimize the catalog, and the adjustment cycle of the essential medicine catalog should not exceed 3 years in principle
.
Recently, the latest news of the basic medicine catalog has been released from time to time in the industry.
According to the latest news, the adjustment of the basic medicine catalog will be divided into three parts: chemical medicine and biological medicine, traditional Chinese medicine and children's medicine.
Focus on
.
  

  On the payment side, the medical insurance fund's support for children's medicines is also increasing
.
The results of the 2020 national medical insurance negotiations were officially announced on December 28 last year, and the new catalog was launched on March 1 this year
.
A total of 119 drugs were included this time.
In addition to anti-tumor drugs that are of high concern in the industry, diabetes drugs, respiratory system drugs, children's drugs, antidepressants, and rare disease drugs are also included
.
  

  Among them, the medical insurance negotiations included a total of 7 pediatric drugs, including Xiaoer Qingrening Granules, Pediatric Faropenem Granules, Xiaoer Niuhuang Qingxin Powder, Xiaoer Jingxing Cough Granules, Anerning Granules, etc.
, mostly Chinese patent medicines, and they are also clinical pediatric drugs.
Commonly used varieties
.
Taking Xiaoer Jingxing Cough Granules as an example, the drug is mainly used for bronchitis
.
According to data from Minai.
com, proprietary Chinese medicines for cough and expectorant use account for a huge market share of Chinese patent medicines for children.
In 2020, the market size of Chinese patent medicines for cough and expectorant drugs for children in China has exceeded 10 billion yuan
.
  

  As the safety and demand of children's medicines are highly valued, the market demand for children's medicines in China is increasing
.
The industry predicts that China’s children’s drug market will exceed 200 billion yuan in 2021, and it will continue to maintain an average annual growth rate of more than double digits
.
At the same time, the supply and transformation and upgrading of China's children's drug market will also usher in an explosion
.